FDA 510(k) Application Details - K990160

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K990160
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant INFLUENCE, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004 US
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Contact JONATHAN S KAHAN
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 01/19/1999
Decision Date 02/16/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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